SAP authoring, review tracking, and alignment with study objectives.
The Statistical Analysis Plans module manages the end-to-end SAP lifecycle from authoring through review, approval, and execution. Track SAP versions, review cycles, and alignment with study objectives and endpoints. The module ensures statistical analysis approaches are documented, reviewed, and locked before database lock.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Create SAPs with structured sections covering objectives, endpoints, analysis populations, and statistical methods.
Track SAP through multi-reviewer approval with comments, revisions, and final lock.
Draft Created
Biostatistics Review
Medical Review
Regulatory Review
Sponsor Approval
SAP Locked
Visual mapping of endpoints to analysis methods, populations, and timing.
| Endpoint | Type | Analysis Method | Population | Timing |
|---|---|---|---|---|
| Overall Survival | Primary | Log-rank, Kaplan-Meier | ITT | Final |
| PFS | Secondary | Log-rank, KM | ITT | Interim + Final |
| ORR | Secondary | Chi-square, CI | ITT | Interim |
| DOR | Exploratory | Descriptive stats | Responders | Final |
| Safety | Safety | Summary by SOC/PT | Safety | Continuous |
How Statistical Analysis Plans integrates with other CTMS modules in the platform.
SAP aligned with study objectives and protocol
SAP defines dashboard analytics parameters
SAP requires formal approval workflow
SAP stored and submitted via vault